The present invention relates to the field of coagulation and hemostasis.
With the aging of the population the risk of diseases involving the heart and circulation system has become a growing concern. Anticoagulants have been used to combat and/or manage (e.g., prevent) syndromes including atrial fibrillation, pulmonary embolism, deep vein thrombosis, venous thromboembolism, congestive heart failure, stroke, myocardial infarction, and hypercoagulability in patients. In the past, the anticoagulant drug warfarin, which reduced the functional levels of all of the vitamin K-dependent clotting factors, was often used. However, recently improved anticoagulants have been developed that specifically target certain factors in the coagulation cascade.
For example, the introduction of oral anticoagulants has changed the management of patients with venous and arterial thromboembolic diseases. Unlike traditional oral vitamin K antagonists (VKA), the recently developed oral anticoagulant that do not universally reduce vitamin K-dependent factors are given at fixed doses and have a lower potential for drug and food interactions, thus eliminating the requirement for routine laboratory monitoring (Ansell J. et al., Chest 133: 160S-198S, 2008; Ageno W. et al., Chest 141: e44S-88S, 2012). These novel agents show similar or improved efficacy and safety profiles compared with VKA drugs such as warfarin and established parenteral agents including unfractionated heparin and low molecular weight heparin.
However, these new oral anticoagulants present management challenges to both clinicians and laboratory personnel when patients develop bleeding diatheses (e.g., due to a traumatic injury or during surgery). Lack of a readily available method to determine the degree of anticoagulation creates a major challenge to clinicians treating bleeding patients who are potentially receiving an anticoagulant. In some cases, there are no useful methods to detect and monitor these agents (see Miyares and Davis, Am. J. Health. Syst. Pharm. 69: 1473-1484, 2012).
It would be useful to have a rapid method to detect the presence of an anticoagulant in a sample taken from the patient. It would also be useful to identify which type of anticoagulant is in the patient's sample.